Validation Engineer

Sr. Validation Engineer (CQV)

Location: U.S. (Hybrid – project-based travel required)

Industry: Life Sciences / Pharmaceutical / Medical Device

Employment Type: Contract / Project-Based

About the Role

Join a team of engineering and regulatory compliance experts delivering capital project CQV solutions for leading life sciences and pharmaceutical manufacturers. This role supports critical projects that improve manufacturing performance, compliance, and product quality from concept through startup.

You’ll work directly with clients, vendors, and project teams to deliver high-quality validation and commissioning deliverables in GMP-regulated environments.

What You’ll Do

• Support capital project CQV activities from design through startup
• Work with clients and vendors during early design to embed compliance, testability, and lifecycle requirements
• Develop User Requirement Specifications (URS) for critical equipment and systems
• Perform risk assessments focused on critical quality attributes
• Author and execute validation and FDA compliance documentation
• Manage commissioning & qualification documentation for utilities, facilities, and process equipment
• Develop and execute FAT, SAT, IQ, and OQ protocols
• Investigate and troubleshoot validation-related issues
• Prepare detailed validation reports and documentation packages
• Work within digital validation tools and modern CQV methodologies

What You Bring

Experience

• 7+ years in validation, commissioning, or CQV roles
• Experience in pharmaceutical or medical device GMP environments
• Background in:
• Aseptic fill/finish or sterile manufacturing (preferred)
• Drug substance or drug product systems (e.g., centrifugation, TFF, pooling, inspection, packaging)
• Utilities, HVAC, or facility qualification

Technical Expertise

• Strong knowledge of GMP regulations:
• 21 CFR Parts 210, 211, 11
• EU Annex 1
• ICH Q7 / Q8 / Q9
• ISPE Baseline Guides
• Experience with:
• IQ / OQ / PQ
• FAT / SAT
• Validation Master Plans (VMP)
• Risk assessments, deviations, change controls
• URS development
• Risk-based validation approach (C&Q preferred)

Skills & Tools

• Strong technical writing and communication skills
• Microsoft Office (Excel, Word, Project)
• AutoCAD (preferred)
• Ability to manage full project lifecycle (design → startup)